NCT02558738已完成不适用
Non Interventional Study (NIS): Clinical Investigation for Evaluation of the Safety and Efficacy of Ectoin Ear Spray and Normison Ear Spray in Skin Treatment of Outer Ear Canal Irritations: A Mulitcenter Non Interventional Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Pruritus at outer ear canal
研究概览
简要总结
In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •according to instructions for use
排除标准
- •otitis media, acute otitis media
- •acute otitis externa
- •perforation of the ear-drum (membrana tympani)
- •infections at the ear
- •systemic corticosteroid treatment or local at the ear
研究组 & 干预措施
Ectoin Ear Spray
treatment according to instruction for use
干预措施: ear spray (Device)
Normison ear spray
treatment according to instruction for use
干预措施: ear spray (Device)
结局指标
主要结局
Pruritus at outer ear canal
时间窗: 14 days
assessment of the symptoms on visual analogous scale
次要结局
- Severity of pruritus(14 days)
- Dermatitis(14 days)
- burning issue on skin(14 days)
- Tolerability(14 days)
- Efficacy(14 days)
- Change in number of adverse events(14 days)
- Tolerability: change in VAS score(14 days)
- Efficacy: change in VAS score(14 days)
研究者
研究点 (4)
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